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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Dow
Cipla
Farmers Insurance
Cantor Fitzgerald
Chinese Patent Office
Medtronic
Baxter
Deloitte
Chubb

Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021127

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NDA 021127 describes OPTIVAR, which is a drug marketed by Mylan Speciality Lp and is included in one NDA. It is available from one supplier. Additional details are available on the OPTIVAR profile page.

The generic ingredient in OPTIVAR is azelastine hydrochloride. There are twelve drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the azelastine hydrochloride profile page.

Summary for 021127

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Ophthalmic Agents
Respiratory Tract Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 021127

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OPTIVAR azelastine hydrochloride SOLUTION/DROPS;OPHTHALMIC 021127 NDA AUTHORIZED GENERIC Wallace Pharmaceuticals Inc. 51525-7815 51525-7815-6 1 BOTTLE, PLASTIC in 1 BOX (51525-7815-6) > 6 mL in 1 BOTTLE, PLASTIC

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.05%
Approval Date:May 22, 2000TE:ATRLD:Yes

Expired Orange Book Patents for NDA: 021127

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan Speciality LpOPTIVARazelastine hydrochlorideSOLUTION/DROPS;OPHTHALMIC021127-001May 22, 2000► Subscribe► Subscribe
Mylan Speciality LpOPTIVARazelastine hydrochlorideSOLUTION/DROPS;OPHTHALMIC021127-001May 22, 2000► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

US Army
Chubb
Dow
Citi
Farmers Insurance
Mallinckrodt
Cantor Fitzgerald
Argus Health
Covington
Merck

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